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Senate passes drug pricing legislation

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions1. The bill generally revives...


CMS proposes sweeping changes to regenerative medicine reimbursement framework

Last month, the Centers for Medicare & Medicaid Services (CMS) released new and significant proposals impacting Medicare coding, coverage, and reimbursement for a class of regenerative...


A survey of President Biden’s Executive Order on promoting competition in the American economy

It has been one year since President Biden signed a far-reaching, industry-spanning Executive Order on Promoting Competition in the American Economy. The Executive Order outlines a...


New circuit split on evidence needed to prove a kickback renders a claim false or fraudulent

The Eighth Circuit released an opinion Tuesday in U.S. ex rel. Cairns v. D.S. Medical LLC that creates a new circuit split on the interpretation of the causation standard for establishing...


World Stem Cell Summit panel compares global trends in regenerative medicine regulations

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlott...


Spotlight on Greater China: internal investigations and enforcement trends in the life sciences sector
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As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and also for companies based in the region,...


Government declines to appeal ruling in PBM accumulator programs MDRP final rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s...


UK government announces its proposals for regulating AI

On 18 July 2022, the UK government published its cross-sector proposal for regulating artificial intelligence. The proposal outlines what is referred to as a ‘pro-innovation’...


Gene therapy development in Europe brings layers of liability risks

The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably...

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